February 14, 2023
The 7th European Association of Authorised Representatives (EAAR) Annual Conference on New Medical Device Regulations took place in early February 2023 in Brussels. The two-day regulatory conference featured speakers such as:
- Representatives of the European Commission (EC),
- MedTech Europe,
- Head of the department Medical devices, FAMHP (Belgium Competent Authority),
- Global Medical Devices Certification Manager, SGS (1639)
- Head of IVD certifications, BSI NL (2797)
- Senior Regulatory affairs specialist of the UK Medicines and Healthcare products Regulatory Agency (MHRA)
- Head of UK Approved Body & Senior Regulatory Lead, Regulatory Services (Medical Devices), BSI UK (0086)
- Director of Team-NB (Medical Devices Notified Bodies Association)
Below, we cover some highlights of the EAAR conference.
The two-day conference provided great insights into the current state of play in the EU market, the expected actions of the European Commission to tackle challenges related to shortages of devices and capacity among Notified Bodies (NBs).
The Belgium FAMHP gave some insights into how they process article 59 MDR derogation requests and article 97 MDR applications.
MedTech Europe and the EC gave an update on the amendment to MDR and IVDR transition timeframes The council gave the green light to send the document to the European parliament without any changes. Because there are no changes, there is no need to discuss the amendment again within the council, which saves time. It is expected that the amendment will be published in the Official Journal of the EU (OJEU) mid-spring this year.
There are, however, terms and definitions in the amendment that require clarification. Such as the “agreement between the mfr. and NB.” What does that agreement need to reflect, or did the EC intend to say “a signed contract for starting the conformity assessment” which is something very different and will take longer than five months (quite often) to issue? It is important for manufacturers to know what is expected in order to be able to make effective use of the new transitional provisions in the amendment.
As a member of the Medical Device Coordination Group (MDCG) stakeholder meeting, Emergo by UL continues to monitor this situation, and will provide updates as they become available.
MDR assessment best practices
SGS and Team NB gave some great insights into issues they frequently find during medical device conformity assessments, and provided some food for thought.
For example, keep in mind that even if your Medical Devices Directive (MDD) certificate is extended by amendment, make sure:
- To keep transitioning to the MDR, as you will pay double for the MDR contract and MDD surveillances. Plus, you’ll be required to maintain two Technical Dossiers (TD) until you are fully transitioned to the MDR.
- An important point to consider is that a TD can only cover more than one device if these devices have a common preclinical report, Risk Assessment, clinical evaluation report (CER) and EMDN/GMDN coding (i.e., same generic device group)
- Planning is key! NB review timelines under the MDR are longer, and the availability of auditors is limited, so they need to book slots for review.
- Even if your TD is not ready yet, apply with your NB for MDR certification. Provide your timeline on when you expect to be ready. As indicated, there are limited auditors and NBs can schedule audits well in advance of receiving your application.
- Commonly observed issues:
- Difficulty navigating through files, necessitating greater transparency, accessibility and searchability of documentation
- Inconsistent data
- Missing documents
- Old data, which should be removed to meet “state of the art” requirements
- Insufficient clinical data – must cover the user group as targeted in the IFU
- CER not covering all or only partial covering clinical indications
- Insufficient justification for why no clinical investigation has been conducted
- Missing GSPR justification of “N/A”
Another important takeaway: Team-NB emphasizes the importance of requesting a Single Registration Number (SRN), and that manufacturers lodge their applications for MDR/IVDR certification.
Not only Medical Devices but also IVDs were discussed at the EAAR conference. The IVD sector faces possibly even bigger challenges than the medical device sector. Most self-certified IVDs under the In Vitro Medical Devices Directive (IVDD) are up-classified under the IVDR and need NB involvement. However, currently only a small number of NBs are designated to issue CE certificates under the IVDR.
Some important topics that were discussed:
- The new amendment makes the sell-off date of medical devices and IVDs indefinite; however, many IVDs will have an expiry date. Manufacturers need to take into account that some accessories that do not have an expiry date and are still circulating in the EU may remain in the market while the IVDs linked to these accessories might have changed. This could potentially lead to compatibility issues.
- MDCG 2022-18 does not mention art. 92 IVDR, which is equivalent to article 97 MDR. Nevertheless, IVD manufacturers could also use article 92 IVDR under certain circumstances to maintain market access if they have not yet obtained valid IVDR certificates. Since a relatively small number of IVDD certificates have been issued, the article 92 IVDR route will most likely have a limited effect for IVD manufacturers, though it might be of relevance.
- The biggest IVDR certification bottleneck at the moment is for class D devices, due to the absence of EU Reference Labs (EURLs). MDCG 2021-4 does state that NBs can proceed with the review of Class D devices without the EURLs. Nevertheless, in that case the NB will require an external lab to have performed similar testing. The EC expects the first EURLs to be appointed by the end of 2023.
- IVD NBs do have more capacity at the moment, but despite this, they have so far received only limited applications. Some applications have even been withdrawn.
Market access in the UK
Not only the amendment was discussed, but also best practices and lessons learned from NBs during assessments of UKCA conformity assessments.
- The new transition timeline ends June 20, 2024, for medical devices and June 20, 2029 for IVDs. The MHRA might adjust the transition timelines to align with the new EU amendment transition timelines
- Currently in the UK manufacturers can leverage CE marking or UKCA marking
- Some NBs designated in the EU are also designated in the UK. These bodies can perform combined assessments in the event of a UKCA review and MDR review, which will save a manufacturer significant time to market in both the UK and EU
- The most frequently found non-conformities during a UKCA review relate to referencing the European directives but not UK regulations
- There are standards harmonized in the UK. However, these are not published in the OJEU, obviously. Manufacturers are expected to follow EU standards, in the event, there is no harmonized standard available yet in the UK. The EU harmonized standards contain an “Annex ZA” which contains a correlation table linking the clause of the standard and the relevant legal requirement in the EU Regulation(s)/Directive(s). These Annex ZA’s overlap with the UK MDR 2002, as well. A UK Conformity Assessment Body expects the UK harmonized standards to be referenced throughout a manufacturers’ Technical Documentation.
If you haven’t been able to join this year’s EAAR Annual Conference on New Medical Device Regulations, certainly join next year. In the meanwhile. Emergo will keep monitoring regulatory updates in the EU and UK and keep you posted.
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